SUSPECT ADVERSE REACTION REPORT

Transcription

1 CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM I. REACTION INFORMATION 1. PATIENT INITIALS 1a. COUNTRY 2. DATE OF BIRTH 2a. AGE 3. SEX 4-6 REACTION ONSET privacy DE DA MO YR ( ): Dry skin ] ( ): Itching ] ( ): Depression ] Hautausschlag am ganzen Körper ( ): Skin rash ] dunkle Flecken unter der Haut ( ): Skin blotches ] Mundaphten ( ): Oral aphthae ] ( ): Visual disturbance ] Case narrative including clinical course, therapeutic measures, outcome and additional relevant information: Bericht aus der Bevölkerung: Folgende Nebenwirkungen sind nach der Einnahme von Omeprazol wegen Refluxoesophagitis bei mir aufgetreten: Ich habe seitdem furchtbaren Hautausschlag am ganzen Körper, der nicht mehr wegzukriegen ist. Außerdem dunkle Flecken unter der Haut, Mundaphten und Sehstörungen. Ergänzende Meldung des behandelnden Arztes : 76 DA MO YR (Year) Female 8-12 CHECK ALL APPROPRIATE TO ADVERSE REACTION DESCRIBE REACTION(S) (including relevant tests/lab data) (cont.) PATIENT DIED INVOLVED OR PROLONGED INPATIENT HOSPITALISATION INVOLVED PERSISTENCE OR SIGNIFICANT DISABILITY OR INCAPACITY LIFE THREATENING CONGENITAL ANOMALY / BIRTH DEFECT OTHER MEDICALLY IMPORTANT CONDITION II. SUSPECT DRUG(S) INFORMATION 14. SUSPECT DRUG(S) (include generic name) (cont.) omeprazol ratio 40 nt 15. DAILY DOSE(S) 16. ROUTE(S) OF ADMINISTRATION "daily dose: 40 Mg milligram(s) every Day" [ Mg Oral milligram(s) { 40 Mg milligram(s), 1 in 1 Day } ] 17. INDICATION(S) FOR USE Reflux oesophagitis 18. THERAPY DATES (from/to) 19. THERAPY DURATION from 20-MAY-2014 to 08-SEP- 3 Year III. CONCOMITANT DRUG(S) AND HISTORY 22. CONCOMITANT DRUG(S) AND DATES OF ADMINISTRATION (exclude those used to treat reaction) DID REACTION ABATE AFTER STOPPING DRUG? YES NO NA DID REACTION REAPPEAR AFTER REINTRODUCTION? YES NO NA 23. OTHER RELEVANT HISTORY (e.g. diagnostics, allergics, pregnancy with last month of period, etc.) [ MedDRA 20.0 ( ): Reflux oesophagitis ] Continuing: [ MedDRA 20.0 ( ): Intrinsic asthma ] Continuing: [ MedDRA 20.0 ( ): Neurodermatitis ] Continuing: (cont.) 24a. NAME AND ADRESS OF SENDER Bonn, DE IV. SENDER INFORMATION 24c. DATE RECEIVED BY MANUFACTURER 12-OCT- DATE OF THIS REPORT 24b. MFR CONTROL NO. DE-BFARM d. REPORT SOURCE þ STUDY 25a. REPORT TYPE LITERATURE HEALTH PROFESSIONAL þ INITIAL FOLLOW UP FINAL (Cont.) = Continuation on attached sheet(s)

2 Report Page: 2 of Describe Reaction(s) (including relevant tests/lab data) (... continuation...) AM früher gegeben und vertragen. Verlauf der Therapie der UAW: Pat. hat Omeprazol nach Studium des Beipackzettels abgesetzt und Rauchen aufgehört. Weitere Bemerkungen: Am ehesten im Rahmen der Grunderkrankungen aufgetretene Erscheinungen. Results of tests and procedures relevant to the investigation of the patient: Veränderung von Laborparametern in Zusammenhang mit der UAW: kein Labor Reaction text as reported MedDRA coding Duration Outcome* Term highlighted Time interval 1** Time interval 2*** Start date End date Hautausschlag am ganzen Körper [MedDRA 20.0 PT ( ): Rash ] ( ): Skin rash ] dunkle Flecken unter der Haut [MedDRA 20.0 PT ( ): Rash macular ] ( ): Skin blotches ] Mundaphten [MedDRA 20.0 PT ( ): Aphthous ulcer ] ( ): Oral aphthae ] [MedDRA 20.0 PT ( ): Visual impairment ] ( ): Visual disturbance ] [MedDRA 20.0 PT ( ): Dry skin ] ( ): Dry skin ] [MedDRA 20.0 PT ( ): Pruritus ] ( ): Itching ] [MedDRA 20.0 PT ( ): Depression ] ( ): Depression ] * Outcome of reaction/event at the time of last observation ** Time interval between beginning of suspect drug administration and start of reaction/event *** Time interval between last dose and start of reaction/event Results of tests Date Test Result Unit rmal low range rmal high range More inform. available 14. Suspect Drug(s) (including generic name) (... continuation...)

3 Report Page: 3 of 5 Suspect Drug and batch no. Start date End date Duration Dose * Route(s) of Administration Indication(s) omeprazol ratio 40 nt Identification of the country where the drug was obtained 20-MAY- 08-SEP Year A: daily dose: 40 Mg milligram(s) every Day B: 38320Mg milligram(s) C: 40Mg milligram(s) D: 1 E: 1Day Oral Reflux oesophagitis Name of holder/applicant ratiopharm GmbH Authorization/Application Number Country of authorization/application Pharmaceutical form (Dosage form) Parent route of administration (in case of a parent child/fetus report) Gestation period at time of exposure Time interval between beginning of drug administration and start of reaction/event Time interval between last dose of drug and start of reaction/event Action(s) taken with drug Drug withdrawn Additional information on drug Did reaction reappear after reintroduction? * A: Dosage Text B: Cumulative dose number (to first reaction) C: Structure dosages number D: Number of separate dosages E: Number of units in the interval Active drug substance name omeprazole Causality assessment Reaction Source Method Result [ MedDRA 20.0 ( ): Dry skin ] [ MedDRA 20.0 ( ): Itching ] [ MedDRA 20.0 ( ): Depression ] 23. Other relevant history (... continuation...) Reactions, Symptoms and Events Start date End date Continuing Comments [ MedDRA 20.0 ( ): Reflux oesophagitis ] Refluxösophagitis (Hiatusinsuffizienz) [ MedDRA 20.0 ( ): Intrinsic asthma ] [ MedDRA 20.0 ( ): Neurodermatitis ] [ MedDRA 20.0 ( ): Depression ] Depression seit Jahren

4 Report Page: 4 of 5 [ MedDRA 20.0 ( ): Arthrosis ] [ MedDRA 20.0 ( ): Hypertension ] [ MedDRA 20.0 ( ): Basalioma ] [ MedDRA 20.0 ( ): Macular degeneration ] [ MedDRA 20.0 ( ): Lip squamous cell carcinoma ] [ MedDRA 20.0 ( ): Smoker ] [ MedDRA 20.0 ( ): Drug intolerance ] Patient past drug therapy Name of drug as reported Indication MedDRA code Reactions MedDRA code Start date End date pantoprazol [ MedDRA 20.0 (0): unbekannt ] [ MedDRA 20.0 ( ): Adverse drug reaction ] ass [ MedDRA 20.0 (0): unbekannt ] [ MedDRA 20.0 ( ): Allergy NOS ] amlodipin [ MedDRA 20.0 (0): unbekannt ] [ MedDRA 20.0 ( ): Face red ] candesartan [ MedDRA 20.0 (0): unbekannt ] [ MedDRA 20.0 ( ): Skin rash ] ADMINISTRATIVE AND IDENTIFICATION INFORMATION Safetyreportversion 1 Identification of the country where the reaction/event occur Serious Date Format of receipt of the most recent information for this report Additional documents 1012 List of documents held by sender Does this case fulfill the local criteria for an expedited report? Regulatory authority's case report number Other case identifiers in previous transmissions Was the case medically confirmed, if not initially from health professional? Yes Primary source(s) of information Reporter postcode Reporter country Qualification Literature reference(s) Study name Sponsor study number Study type in which the reaction(s)/event(s) were observed 71 Consumer or other non health professional 71 Physician

5 Report Page: 5 of 5 SENDER INFORMATION (... continuation...) Type Organisation Department Regulatory Authority Street address City Bonn Postcode Country Fax Telephone address uaw@bfarm.de PATIENT INFORMATION (... continuation...) Investigation number Gestation period Patient age group Elderly >65.Lj. Weight (kg) 70 Height (cm) 167 Last menstrual periode date Text for relevant medical history and concurrent conditions Pantoprazol nicht vertragen; Allergie auf ASS; Amlodipin: roter Kopf; Candesartan: evtl. Hautausschlag